吉西他滨联合顺铂与吉西他滨联合去甲长春碱治疗非小细胞肺癌的随机对照研究

A randomized clinical trial of gemcitabine plus cisplatin compared with gemcitabine plus vinorelbine in the treatment of non-small cell lung cancer

背景与目的含铂类方案目前是晚期非小细胞肺癌(NSCLC)的标准治疗,但其严重的不良反应促使人们寻找新的替代方案。本研究拟比较吉西他滨联合顺铂(GP)方案与吉西他滨联合去甲长春碱(GN)方案治疗晚期NSCLC的疗效、生存率及毒副反应。方法对103例经病理或细胞学证实的晚期NSCLC的初治患者给予联合化疗,随机分为GP组或GN组。GP方案组52例,GN方案组51例,两组病例具有可比性。吉西他滨1000mg/m2,静脉滴注第1、8天,顺铂80mg/m2,静脉滴注第1天,去甲长春碱25mg/m2静脉推注第1、8天。21天为一个周期。每例患者治疗不超过6个周期。结果GP组患者总有效率为34.6%,1年生存率为68.8%,中位生存期14.4个月;GN组患者总有效率为27.5%,1年生存率为73.1%,中位生存期19.5个月。两组间有效率、1年生存率比较差异无显著性。最常见的毒副反应为恶心及呕吐,GP组和GN组的Ⅲ+Ⅳ度反应发生率分别为51.9%和2.0%,差别有统计学意义(P=0.0005)。其余毒副反应轻微,可耐受。结论吉西他滨联合顺铂与吉西他滨联合去甲长春碱相比,疗效相似,但吉西他滨联合去甲长春碱方案的毒副反应(恶心/呕吐)小于吉西他滨联合顺铂方案。

Background and objective Although platinum-based chemotherapy has become a standard treatment for non-small cell lung cancer （NSCLC）, its severe toxicities limit clinical application and a new alternative regimen is required. The aim of this study was to assess efficacy, survival rate and toxicity of gemcitabine＋cisplatin regimen （GP） versus gemcitabine ＋vinorelbine regimen （GN） in the treatment of advanced NSCLC patients. Methods One hundred and three patients with stage Ⅲ or Ⅳ NSCLC were enrolled into this study, and 52 patients and 51 patients were randomly divided into GP group and GN group respectively. Gemcitabine 1 000 mg/m^2 on days 1 and 8 and cisplatin 80 mg/m^2 on day 1 were administered to patients in GP group, while gemcitabine 1 000 mg/m^2 on days 1 and 8 and vinorelbine 25 mg/m^2 on days 1 and 8 were given to patients in GN group. Both regimens were repeated every 3 weeks, no more than 6 cycles for each patient. Resuits An objective response rate of 34.6% was observed in GP arm versus 27.5% in GN arm and 1-year survival rate was 68.8% in GP arm and 73.1% in GN arm with no significant difference in statistical analysis （P〈0.05）. The median survival time was 19.5 months for GN arm and 14.4 months for GP arm. Nausea and vomiting were the major dose-limiting toxicity. The incidence of grade Ⅲ- Ⅳ nausea and vomiting was significantly higher in GP arm than that in GN arm （51.9% vs 2.0%, P =0 .0005）. Conclusion Both GP regimen and GN regimen are effective regimens when used in Chinese advanced NSCLC patients, however grade Ⅲ-Ⅳ nausea and vomiting in GP regimen are significantly lower than that in GP regimen.